CONEX- dexbrompheniramine maleate, pseudoephedrine hcl tablet 
LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DRUG FACTS

Active Ingredients (in each film coated tablet)                         Purpose

Dexbrompheniramine Maleate, USP ................ 2 mg .................. Antihistamine

Pseudeophedrine HCl, USP .................... 60 mg ..........................Nasal Decogestant


Uses

Warnings:

Ask a doctor before you use if you are
Ask your doctor before use if you have
When using this product
Stop use and ask doctor if

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

If pregnant or breast-feeding, ask a health professional before use.

Do not use if you are taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions

or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you  do not know if you are taking a prescription drug that contains MAOI;

ask your doctor or pharmacist before taking this product.

Directions; Do not exceed more than 4 tablets in any 24-hour period or as directed by a doctor.

 Adults and children
 12 years of age and over
 Take one tablet
 every 4 to 6 hours
 Children 6 to under
 12 years of age
 1/2 tablet
 every 4 to 6 hours
 Children under
 6 years of age
 Ask a doctor

Other Information: Store at controlled room temperature 20 - 25 degree celsius (68 - 77 degree fahrenheit); excursions permitted to

15 - 30 degree celsius ( 59 - 86 degree fahrenheit) [ See USP Controlled Room Temperature] Tamper evident by imprinted heat seal

under cap. Do not use if there is evidence of tampering.

Inactive Ingredients: Dicalcium Phosphate, Microcrystalline Cellulose, Magnesium Stearate, Sodium Starch Glycolate type B, Purified Water, Red iron Oxide, Yellow Iron Oxide, Titanium Dioxide.

Questions or Comments?                 1-866-595-5598

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CONEX 
dexbrompheniramine maleate, pseudoephedrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54859-702
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP) DEXBROMPHENIRAMINE MALEATE2 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE60 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM STARCH GLYCOLATE TYPE B POTATO (UNII: 27NA468985)  
WATER (UNII: 059QF0KO0R)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize13mm
FlavorImprint Code LLORENS
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54859-702-6060 in 1 BOTTLE; Type 0: Not a Combination Product11/01/2007
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/01/2007
Labeler - LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION (037342305)
Registrant - LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION (037342305)

Revised: 12/2020
Document Id: 21a5aaa5-eb19-425d-b026-47efa1c04bdc
Set id: 82f9f52c-797e-4842-9c9a-40213181d99a
Version: 3
Effective Time: 20201223
 
LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION